tbuckley/cabot-search huggingface dataset:
Patterns of diversity in cancer clinical trial enrollment at a New York City academic health system, 2018-2022.
Authors: Carlos Rodriguez-Russo, Manjeet Chadha, Jennifer Cocco, Karyn A. Goodman
Journal: Journal of Clinical Oncology (2023)

e18630 Background: Mitigation of cancer clinical trial (CT) enrollment disparities is increasingly prioritized in healthcare, but disparity metrics are inconsistently published by individual health systems. We aimed to assess health-system-level trends in CT enrollment by race, ethnicity, sex, and treatment location (network vs main hospital) during the COVID-19 pandemic, as well as to evaluate county-level disparities in CT accrual fraction (AF) over a five-year period. Methods: This was a cross-sectional study of the population enrolled on therapeutic cancer CTs in a New York City academic health system (AHS) from 2018-2022. Demographics were descriptively analyzed and compared with most recent public NCI-reported therapeutic trial accrual data. New York County 5-year cancer incidence was estimated for each demographic subgroup using age-adjusted cancer incidence rates from public SEER/NPCR data and US Census data. Primary endpoint was AF, defined as proportion of patients accrued relative to cancer incidence. Results: Of 2,533 patients enrolled on CTs over the 5-year period, 51% were White, 18% Black, 17% Hispanic, 9.8% Asian, 0.08% American Indian/AK Native, 0% Pacific Islander, and 3.9% Multiple/unknown race; 47% were female. Minority accrual proportion was higher than that of NCI accrual data (45% vs 25%, p =&lt; 0.001). Annual enrollment fell from maximum 571 patients in 2019 to 457 in 2020, then increased to 499 by 2022. Meanwhile, the proportion of minority enrollment increased to a peak of 49.2% in 2020 and fell to 45% in 2022. Female enrollment of 49% in 2018 decreased to 42% in 2021, increasing sharply to 51% in 2022. On multivariate analysis, Black and Asian patients were more likely to be enrolled after the start of the pandemic than White patients (ORs 1.3, 95% CI 1.1-1.6; 1.4, 1.03-1.8). Black, Asian, and female patients were more likely to be enrolled at network hospital locations than White or male patients, respectively (ORs 1.9, 95% CI 1.3-2.7; 2, 1.2-3.1; 14, 8.6-21). Relative to county-level estimated cancer incidence, Black patients had a higher AF than White patients (0.96% vs 0.77%, OR 1.3, 95% CI 1.1-1.4), while Hispanic patients had a lower AF (0.55%, OR 0.72, 95% CI 0.64-0.8). Women had a lower AF than men (0.66% vs 0.74%, OR 0.9, 95% CI 0.83-0.97). Conclusions: Minority accrual at this AHS was higher than nationally reported. Despite decreased total accrual numbers in 2020 due to the COVID-19 pandemic, high accrual diversity was maintained. County-level AF disparities among women and Hispanic patients suggest opportunities for improvement in community outreach, and greater diversity of clinical trial enrollees at network hospitals may reflect successful outreach to the communities they serve.
Integrated efficacy and safety of brigatinib in patients with ALK TKI-naive advanced <i>ALK</i>+ NSCLC in the ALTA-1L and J-ALTA studies.
Authors: D. Ross Camidge, Shunichi Sugawara, Masashi Kondo, Hye Ryun Kim, Myung-Ju Ahn, James Chih-Hsin Yang, Ji-Youn Han, Maximilian J. Hochmair, Ki Hyeong Lee, Angelo Delmonte, Kentarou Kudou, Takayuki Asato, Yuyin Liu, Florin Vranceanu, Robert J. Fram, Yuichiro Ohe, Sanjay Popat
Journal: Journal of Clinical Oncology (2023)

9078 Background: Brigatinib demonstrated efficacy and manageable safety in patients (pts) with anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI)-naive ALK+ non-small cell lung cancer (NSCLC) in phase 3 (ALTA-1L) and phase 2 (J-ALTA) trials. We present results of integrated efficacy and safety analyses of ALTA-1L and J-ALTA. Methods: ALTA-1L (NCT02737501) and J-ALTA (NCT03410108; conducted in Japan) were open-label, multicenter studies in pts with advanced or metastatic ALK+ NSCLC. Pts in ALTA-1L and in part 3 of J-ALTA were ALK TKI-naive. Stable or asymptomatic brain metastases were allowed in both studies. Pts received brigatinib 180 mg qd (7-day lead-in at 90 mg). Primary endpoints were blinded independent review committee (IRC)-assessed progression-free survival (PFS) in ALTA-1L and IRC-assessed 12-month PFS in the J-ALTA ALK TKI-naive cohort (both per RECIST v 1.1). Secondary endpoints included IRC-assessed objective response rate (ORR), duration of response, intracranial ORR, intracranial PFS, overall survival, and safety. Pooled efficacy and safety data from both studies are presented. Results: The pooled analysis population included 169 pts (ALTA-1L, N = 137; J-ALTA ALK TKI-naive cohort, N = 32). Median follow-up overall was 35.8 months (last pt last contact: ALTA-1L, January 2021; J-ALTA, July 2021). Most (66%) pts were aged &lt; 65 years, 24% had baseline brain metastases, 95% had stage IV disease at study entry, and 21% had received prior chemotherapy for locally advanced or metastatic disease. With brigatinib treatment, median PFS by IRC was 29.3 months (95% CI, 23.9‒44.7). The confirmed ORR was 79% (95% CI, 72‒85%), with 36 complete responses and 97 partial responses. Median duration of response was 38.1 months (95% CI, 22.9‒not reached). Median overall survival was not reached; the 3-year survival rate was 74% (95% CI: 66‒80%; 84 pts at risk). Intracranial ORR and intracranial PFS will be presented. Grade 3/4 treatment-emergent adverse events were reported in 74% of pts; the most common were increased blood creatine phosphokinase (31%), hypertension (18%), and increased lipase (16%). Any grade interstitial lung disease/pneumonitis was reported in 12 (7%) of pts. Adverse events led to treatment discontinuation in 11% of pts. Conclusions: Brigatinib treatment demonstrated clinically meaningful systemic and intracranial efficacy in this integrated analysis of pts with ALK TKI-naive advanced or metastatic ALK+ NSCLC in the ALTA-1L or J-ALTA trials. Safety results were consistent with the known profile for brigatinib, with no new safety findings. Clinical trial information: NCT02737501 ; NCT03410108 .
Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study.
Authors: Bartosz Chmielowski, Mohammed M. Milhem, Joseph J. Sacco, Tawnya Lynn Bowles, Katy K. Tsai, Gino Kim In, Eva Muñoz-Couselo, Ari M. Vanderwalde, Jason Alan Chesney, Judith Michels, Adel Samson, Georgia Beasley, Dirk Schadendorf, Fade Mahmoud, Michael K.K. Wong, Trisha Michel Wise-Draper, Junhong Zhu, Praveen Bommareddy, Jeannie W. Hou, Mark R. Middleton
Journal: Journal of Clinical Oncology (2023)

9509 Background: Patients (pts) with melanoma who progress on anti–PD-1 therapy (anti–PD-1–failed) have limited treatment options. RP1 is an HSV-1–based oncolytic immunotherapy expressing human GM-CSF and a fusogenic protein (GALV-GP-R−). Here, we present data from the first 75 pts enrolled into the registration-directed (R-D) cohort in anti–PD-1–failed melanoma (target enrollment N = 125) from the phase 1/2 IGNYTE study (NCT03767348). Methods: Pts must have locally advanced or metastatic cutaneous melanoma with ≥1 measurable and injectable tumor (≥1 cm) and confirmed progressive disease (PD) on 2 assessments ≥28 days apart while on ≥8 consecutive weeks of anti–PD-1 ± anti–CTLA-4 therapy, with anti–PD-1 being the last treatment received. Pts on prior adjuvant anti–PD-1 therapy must have had PD confirmed by biopsy while on adjuvant therapy. RP1 is initially given intratumorally at 10 6 PFU/mL and then every 2 weeks (Q2W) at 10 7 PFU/mL for ≤8 total cycles (≤10 mL/dose) combined with nivolumab (nivo; cycles 2–8, 240 mg IV); pts then receive nivo alone (240 mg Q2W or 480 mg Q4W IV) for ≤2 years, with the option to reinitiate RP1 if specified criteria are met. Results: A total of 91 pts are included in this analysis (initial melanoma cohort, 16 pts; R-D cohort, 75 pts; data cut: Dec 30, 2022). The overall objective response rate (ORR) was 37.4% (initial cohort, 37.5%; R-D cohort, 37.3%) and 18.7% of pts achieved complete response (CR; Table). The response rates seen were also encouraging when evaluated by prior anti–PD-1 therapy setting and disease stage (Table). Responses were seen in uninjected lesions in most responding patients, including in pts with bulky and visceral disease. The majority of responses were observed in pts with PD-L1–negative tumors at baseline (17 of 52 pts with PD-L1–negative tumors responded, compared to 15 of 26 pts with PD-L1–positive tumors, and 2 of 13 pts for whom PD-L1 status was unknown). 85.3% of responses were ongoing 3.7–36.6 months from initiating therapy. Most treatment-related adverse events (TRAEs) were Grade 1–2 with the most common (&gt;20%) being fatigue, chills, pyrexia, and nausea. Conclusions: The initial data from this expanded cohort show that RP1 + nivo provides durable and clinically meaningful antitumor activity in pts with anti–PD-1–failed melanoma. Responses were observed in both injected and uninjected lesions, including visceral lesions. The combination continues to be well tolerated, with mostly on-target TRAEs. Additional and updated data will be presented. Clinical trial information: NCT03767348 . [Table: see text]
Safety and efficacy of immune checkpoint inhibitors in patients with cancer and pre-existing autoimmune disease: A systematic review and meta-analysis in non-small cell lung cancer.
Authors: Wint Yan Aung, Chung-Shien Lee, Jaclyn Morales, Nina Kohn, Husneara Rahman, Nagashree Seetharamu
Journal: Journal of Clinical Oncology (2023)

9053 Background: Cancer patients with pre-existing autoimmune diseases (AID) have been traditionally excluded from clinical trials of immune checkpoint inhibitors (ICI) due to concerns for immune activation leading to toxicity. As indications for ICI expand, there is a need for robust data on safety and efficacy of ICI in cancer patients with AID. Existing studies examined a heterogenous group of cancers and do not include a comparison to cancer patients without pre-existing AID. Therefore, data are lacking concerning how safety and efficacy of ICI in this group of patients may differ from the general population and whether the results are generalizable to non-small cell lung cancer (NSCLC). Methods: We searched for studies consisting of NSCLC, AID, ICI, treatment response, and adverse events using database-controlled vocabulary terms. We systematically searched Medline (PubMed), EMBASE, Scopus, CINAHL, and Web of Science. We selected studies that included NSCLC and excluded abstracts, case reports, review articles, and articles lacking outcomes or populations of interest. Three authors (WA, CL, NS) independently reviewed all abstracts to determine study eligibility and quality. Study quality was assessed using the Newcastle-Ottawa Scale. Study data were pooled using random-effects meta-analysis. Results: Data were extracted from 24 cohort studies, consisting of 10,924 cancer patients, of which 4353 were NSCLC patients. Studies examined a broad spectrum of AID consisting of 1157 patients, of which 291 were NSCLC patients. Pooled analysis revealed an AID flare incidence of 36% (95%CI 27%-46%) in all cancers and 23% (95%CI 9%-40%) in NSCLC. Tests of subgroup difference revealed no significant difference in AID flares by organ system in all cancers and NSCLC (p = 0.602 and p = 0.19, respectively). Pre-existing AID was associated with a higher risk of de novo iRAE in all cancer patients (RR 1.38, 95%CI 1.16-1.65) and in NSCLC patients (RR 1.51, 95%CI 1.12-2.03). There was no difference in de novo grade 3-4 iRAE and tumor response between cancer patients with and without AID. However, in NSCLC patients, pre-existing AID was associated with a 2-fold increased risk of de novo grade 3-4 iRAE (RR 1.95, 95%CI 1.01-3.75) but also better tumor response in achieving a complete or partial response (RR 1.56, 95%CI 1.19-2.04). Conclusions: Pre-existing AID confers an increased risk of toxicity during ICI therapy. NSCLC patients with AID are at a higher risk of de novo grade 3-4 iRAE but are also more likely to achieve treatment response than those without AID. Multidisciplinary collaboration is paramount when considering ICI therapy in this patient population with careful calculation of risk and benefit as well as close monitoring for toxicity.
Treatment patterns for extramedullary multiple myeloma and outcomes with CAR-T therapy and bispecific antibodies.
Authors: Saurabh Zanwar, Matthew Ho, Prashant Kapoor, Moritz Binder, Francis Buadi, Angela Dispenzieri, David Dingli, Amie L. Fonder, Morie A. Gertz, Wilson I. Gonsalves, Suzanne R. Hayman, Yi Lisa Hwa, Miriam A. Hobbs, Taxiarchis Kourelis, Martha Lacy, Nelson Leung, Eli Muchtar, Rahma M. Warsame, S. Vincent Rajkumar, Shaji Kumar
Journal: Journal of Clinical Oncology (2023)

8022 Background: Extramedullary Multiple Myeloma (EMM) is an aggressive entity with a dismal prognosis. Immune effector therapies (IETs), including chimeric antigen receptor T-cell (CAR-T) therapies and bispecific T-cell engaging antibodies (BsAb), have demonstrated excellent efficacy in relapsed/refractory MM with limited data for efficacy in EMM. Here, we report the treatment outcomes for patients with EMM. Methods: We identified 299 patients with EMM diagnosed between 01/01/2000 and 12/31/2021 after excluding solitary plasmacytomas, paraskeletal MM and primary plasma cell leukemia. The IMWG criteria were used for response definition. Results: Of the 299 patients, 204 (68%) patients had secondary EMM (sEMM) and 95 (32%) patients had primary EMM (pEMM). For sEMM (n=204), the median progression free survival (PFS) with initial therapy was 2.9 (95% CI: 2.4-3.2) months. Initial treatment strategies for sEMM were heterogenous and demonstrated in the table; 44% patients achieved ≥partial response (PR) with initial treatment for sEMM. The median PFS in patients with ≥PR was 5.8 (95%CI: 4.5-6.9) months vs 1.8 (95%CI: 1.4-2; p &lt;0.0001) months for &lt;PR. For patients with pEMM (n=95), the median PFS was 12.9 (95% CI: 6.7-18) months; the median PFS was 17.4 (95%CI: 12.9-25.4) months for patients with ≥PR versus 1 month (95%CI: 0.8-2) in patients with &lt;PR. Thirty patients (all sEMM and triple class refractory) were treated with IET after development of EMM: 18 with BCMA-directed CAR-T, 10 with BsAbs, and 2 with both CAR-T and BsAbs. In patients receiving CAR-T therapy, 75% (15/20) achieved ≥PR with 40% (n=8) achieving MRD negative (by flowcytometry) complete response. Fifteen (75%) patients receiving CAR-T had progressive disease (PD); 7 with systemic and EMM PD and 4 patients each with isolated EMM or systemic PD. The median PFS for patients treated with CAR-T was 4.9 months [3.1- not reached (NR)]. Among patients achieving a ≥PR with CAR-T, the median PFS was 5.8 (95%CI: 4.7-NR) months vs 1.4 months [(95%CI: 0.8-NR), p&lt;0.001] for &lt;PR. Among patients treated with BsAbs (10-BCMA, 1 each against FcRH5 and GPRC5D), 33% (4/12) achieved a ≥PR. Ten (83%) patients had PD on BsAb; 8 with both EMM and systemic PD and 1 patient each with isolated EMM or PD. The median PFS with BsAb was 2.9 months (95%CI: 2.2-NR). Conclusions: Patients with EMM continue to have dismal outcomes with conventional therapies. High response rates were noted with CAR-T therapy, but these tend to be short-lived. [Table: see text]
Role of social disparity in 30-day readmissions and healthcare utilization in patients with history of sickle cell crisis in United States: Cross-sectional analysis from US national database.
Authors: Urja Nagadia, Sanket Basida, Swathi Radhakrishnan, Lakshmi Ramya Chelapareddy, Kushal Naha
Journal: Journal of Clinical Oncology (2023)

e18666 Background: Factors like age, mental status, spirituality, financial security, and clinic attendance affect hospital admissions/readmissions in sickle cell disease patients. To further understand the predisposing factors associated with increased readmissions in sickle cell disease patients, this study examined the relationship between readmission rates and socioeconomic status of Sickle cell patients in the US. Methods: All adult hospitalized patients in the Nationwide Readmission Database (NRD) for the year 2019 were captured. The sample population included all patients with primary diagnosis of Sickle cell crisis, identified using ICD-10 codes (International Classification of Diseases, tenth edition). We used the Wilcoxon rank sum test to compare continuous variables and chi square test for categorical variables. Predictors of readmission were analyzed using multivariate logistic regression models. We used StataCorp LLC MP4 17 version to perform statistical analysis. Results: The sample size included 48,715 patients admitted with sickle cell crisis, of which 55.12% were females and 44.88% were males. The mean age of presentation was 32.84 years. The rate of all cause 30-day readmission in patients admitted with Sickle cell crisis was 27.19%. The total hospital charges for these readmitted patients during the year 2019 was 507 million dollars and total length of stay was 69,418 days (about 190 years). The most common causes of readmissions were Sickle cell crisis including Acute chest syndrome and splenic sequestration crisis, followed by sepsis due to MRSA and femoral fractures. After adjusting for confounders on multivariate analysis, compared to patients belonging to income category 1 ( &lt; $46,000), patients in category 2 ($46,000-$58,999) had 11% lower risk (p-value 0.018) and category 3 had 16% lower risk (p-value 0.008) of 30-day readmission. However, there was no increased risk of death based on socioeconomic status (OR 1.03, p-value 0.875). Conclusions: Our study concludes that socioeconomically deprived Sickle cell crisis patients are at higher risk of readmissions. Factors like poor living situation, lack of means for transportation, potential lower level of education leading to decreased medication compliance and clinic follow ups could be attributed to these findings. Interventions targeting this population can help reduce healthcare burden and patient morbidity significantly. [Table: see text]
Genetic evaluations and testing rates for hereditary breast and ovarian cancer syndrome in a community oncology setting.
Authors: Ann Bunnell, Kate Principe, Gayle Patel, Trisha Nichols, Sara Mokhtary, John F. Sandbach, Vanessa Torres
Journal: Journal of Clinical Oncology (2023)

e22533 Background: Several professional medical societies recommend genetic evaluations and testing for individuals with a personal and/or family cancer history. The National Comprehensive Cancer Network (NCCN) outlines germline testing criteria for breast, ovarian, and pancreatic cancer predisposition genes. This study aims to assess the genetic evaluation and testing rates in community oncology centers among patients who qualify based on their personal history of cancer. Methods: A retrospective study assessed patients diagnosed at any Texas Oncology site between 1/01/2017 and 12/31/2019. Using NCCN Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic V1.2020, individuals with the following cancer diagnoses were included: epithelial ovarian, breast &lt; 45 years, triple negative breast &lt; 60 years, metastatic HER2 negative breast, male breast, exocrine pancreatic, or metastatic prostate. Data was obtained from electronic medical records. The project was approved by the Texas Oncology Privacy Board. Results: Of the 10,202 patients included, 6033 (59%) underwent genetic testing. Only 3660 (36%) had a genetic evaluation, and of those, 2720 (74%) were conducted within Texas Oncology. Younger patients were significantly more likely to be tested than those diagnosed at older ages (p = 2.2e-16). Testing rates were significantly higher (p = 8.95e-07) at sites that employ a provider with genetics training; moreover, the rates of evaluation and testing trended upward, the longer those providers had been offering genetics services. Of the patients without test results, most (76%) had neither a genetics referral nor germline test order documented, suggesting an opportunity for provider education. Conclusions: Most patients who met criteria underwent genetic testing, but the rates varied by cancer type. Patients with breast cancer were most likely to have genetic testing. This study proved that having a genetics provider on staff significantly improved testing rates for patients who qualify. However, given that 100% of the cohort qualified and only 59% underwent testing, quality improvement measures are needed to increase the rate of genetic evaluations and testing for these diagnoses. [Table: see text]
Dietary and lifestyle profiles between patients with and without cancer in the national health interview survey.
Authors: Emma Gong, Mingyang Song, Benjamin G Allar, Darren Seto, Wenchao Ma
Journal: Journal of Clinical Oncology (2023)

12073 Background: Although poor diet and lifestyle has been associated with cancer development and progression, it is unclear how the diagnosis of cancer impacts diet and lifestyle. We examined the dietary patterns and overall nutrition of adults diagnosed with cancer versus those never diagnosed with cancer in the 2015 National Health Interview Survey (NHIS). Methods: NHIS adults who reported having cancer (n=2,853) and not having cancer (n=27,002) were identified. A dietary/lifestyle score was developed based on World Cancer Research Fund and American Institute for Cancer Research Cancer Prevention Recommendations (Table). Participants were given a score for each recommendation which was then summed as an overall score, with seven meeting all requirements fully and zero meeting none of the requirements. Results: The mean composite score for the cancer population was 4.28 ± 0.88 and for the noncancer population was 4.30 ± 0.90 (p = 0.18). Compared to patients without cancer, those with a cancer diagnosis had higher rates of adherence to recommendations for fruit/vegetable consumption (0.08 vs. 0.07, p &lt;0.001) and limitation of sugar-sweetened beverages (0.77 vs. 0.74, p &lt;0.001), but had lower rates of the recommended physical activity (0.43 vs. 0.49, p &lt;0.001). Conclusions: Patients with and without diagnosis of cancer had mediocre adherence (4.3 out of 7) to lifestyle recommendations, although those with diagnosis of cancer had a higher consumption of fruits/vegetables, lower consumption of sugary beverages, and lower level of physical activity than those without cancer. The data suggests a cancer diagnosis may prompt change in people’s diet, but may limit their ability to exercise. The magnitude of lifestyle change that one can make after a cancer diagnosis may also be influenced by age or social connections. There is great opportunity for integrating healthy lifestyle interventions into routine cancer care. [Table: see text]